We offer comprehensive USP-NF, EP, FCC and JP monograph testing for many raw materials used in pharmaceutical products. Additionally, AMRI operates the only FDA-regulated, GMP laboratory that provides complete gas testing services following USP test procedures. Our quality assurance group routinely audits each area for strict compliance with cGMP requirements.

Access a complete suite of chemistry-based testing of raw materials, including excipients and active APIs. We can meet the most demanding timelines — regardless of whether you need a two-week or a rush turnaround — because of our expertise, size and capacity.

Our USP/NF compendial analytical testing capabilities include:

  • <181> Identification – Organic Nitrogenous Bases
  • <191> Identification Tests – General
  • <197> Spectrophotometric Identification Tests
  • <201> TLC Identification Test
  • <206> Aluminum
  • <211> Arsenic
  • <216> Calcium, Potassium, and Sodium
  • <223> Limit of Dimethylaniline
  • <221> Chloride and Sulfate
  • <228> Ethylene Oxide and Dioxane
  • <231> Heavy Metals
  • <232> Elemental Impurities – Limits
  • <233> Elemental impurities – Procedures
  • <241> Iron
  • <251> Lead
  • <261> Mercury
  • <271> Readily Carbonizable Substances
  • <281> Residue on Ignition
  • <291> Selenium
  • <311> Alginates Assay
  • <341> Antimicrobial Agents Content
  • <661> Containers
  • Benzyl Alcohol
  • Chlorobutanol
  • Phenol
  • Methylparaben and Propylparaben
  • <401> Fats and Fixed Oils
  • Specific Gravity
  • Melting Temperature
  • Acid Value
  • Ester Value
  • Hydroxyl Value
  • Iodine Value
  • Peroxide Value
  • Saponification Value
  • Fatty Acid Composition
  • <415> Medical Gases Assay
  • <431> Methoxy Determination
  • <461> Nitrogen Determination
  • <466> Ordinary Impurities

Our USP/NF analytical testing capabilities include:

  • <469> Ethylene Glycol, Diethylene Glycol and Triethylene Glycol in Ethoxylated Substances
  • <467> Residual Solvents
  • <471> Oxygen Flask Assay
  • <525> Sulfur Dioxide
  • <591> Zinc
  • <611> Alcohol Determination
  • <616> Bulk Density and Tapped Density of Powders
  • <621> Chromatography
  • <631> Color and Achromity
  • <641> Completeness of Solution
  • <643> Total Organic Carbon
  • <645> Water Conductivity
  • <651> Congealing Temperature
  • <691> Cotton
  • <695> Crystallinity
  • <698> Deliverable Volume
  • <701> Disintegration
  • <711> Dissolution
  • <721> Distilling Range
  • <731> Loss on Drying
  • <733> Loss on Ignition
  • <741> Melting Range or Temperature
  • <781> Optical Rotation
  • <785> Osmolarity
  • <786> Particle Size Distribution
  • <788> Particulate Matter in Injections
  • <791> pH
  • <831> Refractive Index
  • <841> Specific Gravity
  • <851> Spectrophotometry and Light Scattering
  • <891> Thermal Analysis
  • <905> Uniformity of Dosage Units
  • <911> Viscosity
  • <912> Rotational Rheometer Methods
  • <921> Water Determination

Other tests:

  • Monograph-specific chemical, microbiological and physical tests
  • FCC monograph-specific chemical and physical tests
  • European Pharmacopoeia (EP) testing
  • Japanese Pharmacopoeia (JP) testing
  • Physical and physiochemical methods, identification, limit tests, assays and biological tests
  • General tests and monographs
  • Testing per client/vendor methods
  • Validation of compendial methods
  • Verification of compendial methods

Contact our analytical testing team at Whitehouse Labs by clicking below

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